Obesity controlling method

ABSTRACT

A method of controlling obesity by injecting bio-compatible bulking material into the pyloric sphincter area of the stomach. The injection of this material bulks the pyloric sphincter, retarding stomach emptying and producing a feeling of satiation in the patient. The method may be supplemental and augmented by inducing flaccid paralysis of the stomach by injecting botulinum toxin into the muscle tissue of the antrum or fundus of the stomach.

This application is a National Phase Application of International PatentApplication No. PCT/US01/24971, filed Aug. 9, 2001, which claimspriority of U.S. Provisional Application No. 60/224,324, filed Aug. 11,2000.

The present invention relates to a method of controlling obesity byinjecting bio-compatible bulking material into the pyloric sphincterarea of the stomach. The injection of this material bulks the pyloricsphincter, retarding stomach emptying and producing a feeling ofsatiation in the patient.

BACKGROUND OF THE INVENTION

Obesity is one of the major causes of heart disease, lipidabnormalities, hypertension and osteoarthritis. Treatment of obesity hasthe potential to lower the risk of all of these diseases as well asimprove the condition of patients who already suffer from suchillnesses. In addition, it is well known that a large percentage ofAmericans and Europeans are considered to be obese based on height andweight ratios issued by the World Health Organization (WHO). Thesenumbers in conjunction with the dangerous diseases affiliated with orcaused by obesity indicate that there is a substantial need foreffective treatment.

Current weight reduction programs usually include administration ofsystemic medications, which suppress the appetite or reduce the fatand/or sugar uptake of the digest track. However, systemic medicationsoften display side effects some of which may be severe. Dietary changesthat reduce caloric intake are also prescribed for the treatment ofobesity, but such treatment requires rigorous compliance by the patientfor effectiveness and is often ineffective as a result ofnon-compliance. In addition, surgery, which bypasses a portion of thestomach and/or the small intestine, is also used in the treatment ofobesity. Surgical methods, however, are highly invasive and subject apatient to all the possible risks involved with major surgery includinginfection.

Safe and effective treatment is a long felt need in the treatment ofobesity. Because of complications and/or ineffectiveness associated withcurrent treatments a minimally invasive, effective treatment ispreferred and is provided by the method of this invention.

SUMMARY OF THE INVENTION

The present invention provides a minimally invasive method forcontrolling obesity comprising injecting a bio-compatible bulkingmaterial submucosally or intramuscularly into the pyloric area of thestomach in an amount sufficient to cause the lumen of pylorus to narrowand slow gastric emptying.

DETAILED DESCRIPTION OF THE INVENTION

The entire disclosure of U.S. Patent Application No. 60/224,324, filedAug. 11, 2000, is expressly incorporated by reference herein.

The invention is a method of treating obesity in which gastric emptyingis slowed by narrowing the pyloric sphincter or pylorus. The inventioncomprises injecting a bio-compatible bulking material into the pyloricarea of the stomach, preferably either submucosally or intramuscularly.By narrowing the pyloric region of the stomach, the stomach will fillmore quickly and empty more slowly as a patient eats. The clinicaleffect of this treatment will be to increase the time the patient feelssatiated after eating, therefore decreasing the need and desire to eatand reducing the caloric intake of the patient.

The pylorus can be caused to narrow by the injection of a bio-compatiblebulking material into the mucosal or muscular area around the pylorus.Such an injection can be accomplished by a two step process wherein anendoscopy is performed to locate the pylorus and a needle is placedthrough the biopsy channel of the endoscope in order to inject thebulking material. Such an injection will increase the bulk of thepylorus and thus narrow the gastric outlet from the stomach to the startof the small intestines.

The bio-compatible bulking materials suitable for the present inventioninclude collagen, fibrin and elastin as well as other naturallyoccurring and synthetically derived bio-compatible polymers. Certainpolymers such as collagen or fibrin glue have been demonstrated to bewell tolerated when injected into lumen in humans. In addition, suchmaterials are commercially available. For instance, collagen may bepurchased from FribroGen, Inc., Cohesion Technologies, Inc., Hydromer,Inc., and Bard, Inc., and fibrin glue may be purchased from AbbottLaboratories, Inc. Various other similar products for injection include,but are not limited to, Contigen® (Contigen is a registered trademark ofthe Collagen Corporation and is a protein composition for medicalimplants for relief of urinary tract disorders), Zyderm® (Zyderm is aregistered trademark of the Collagen Corporation and is a proteincomposition for dermal implantation), Zyplast® (Zyplast is a registeredtrademark of the Collagen Corporation and is a collagen implant used forsoft tissue augmentation), rh collagen, Dermalogen® (Dermalogen is aregistered trademark of Collagenesis, Inc. and is injectable humantissue for treating wrinkles and scars), Autologen® (Autologen is aregistered trademark of Autogenesis Technologies, Inc. and is processedcollagen for implantation), and autologous fat.

Collagen for use in the present invention can be from several sourcesincluding porcine, bovine, or human. It can be either fibrillar ornonfibrillar. Collagen can be administered in aqueous solution form orin the denatured state as gelatin. In addition, it can be administeredin either a crosslinked or a non-crosslinked form.

Although collagen is preferred as the bio-compatible bulking material tobe injected into the pyloric muscle, other materials can be used. Forinstance, TEFLON paste (Teflon is a registered trademark of DuPont forfluoropolymer resins), synthetic polymeric hydrogels, glycoaminoglycans,proteoglycans, silicone microimplants, Durasphere® (Durasphere is aregistered trademark of Advanced UroScience, Inc. and consists ofbiocompatible, implantable microspheres for local tissue augmentation),and microbeads suspended in biological fluid lubricants such as dextranhave been demonstrated to be tolerated when injected into human lumen.

The amount of bio-compatible bulking material injected into the pyloricarea of the stomach will be dependent of a variety of factors. Forinstance, the size of the individual, the severity of the individual'sobesity, and the shape and distension of the pylorus will all bedeterminative in calculating the amount of bulking material injected. Itis estimated that the opening of the pyloric sphincter can be reduced atleast 10% and up to 90% by the instant invention.

The injection of collagen or fibrin glue into the pylorus is expected tolast for 3 to 12 months. If the body absorbs the bio-compatible bulkingmaterial, it can be re-injected by a repeat of the method described. Ifthe narrowing of the pylorus is found to be too great, the opening canbe increased by the use of a balloon, which can be inserted into thepylorus and inflated to increase the opening. This flexibility inadjusting the pyloric opening to accommodate specific patentrequirements provides a unique advantage over present surgicalprocedures.

While the injection of the bulking bio-compatible bulking material intothe pyloric area will control obesity, the invention may encompassadditional support procedures. For instance, the pyloric area can alsobe narrowed by intentionally scarring the pyloric area with either alaser or a thermal device. In such an embodiment of the invention, alaser or heating device could be placed through the biopsy channel ofthe endoscope and used to cauterize an area of the pylorus. In addition,in another embodiment of the invention, a sewing device could be placedthrough the biopsy channel of the endoscope and used to sew the pylorusand narrow the opening of the pyloric sphincter.

In yet another embodiment of the invention, gastric emptying can befurther delayed by inducing a flaccid paralysis of the of the stomach.Botulinum toxin will cause a paralysis of the stomach if it isstrategically injected into either the muscles of the fundus or theantrum of the stomach. Paralyzing the stomach in this way will prolongsatiety by further delaying gastric emptying. The effects of botulinumtoxin is expected to last for a period of 9 to 18 months.

1. A method of treating obesity comprising: injecting a bio-compatiblebulking material submucosally or intramuscularly into the pyloric areaof the stomach in an amount sufficient to cause the lumen of pylorus tonarrow and slow gastric emptying; sewing the pylorus to narrow thelumen; and treating the pylorus wherein a laser or thermal device isplaced through the biopsy channel and the pylorus is scarred with saiddevice to narrow the lumen.
 2. The method of claim 1, wherein saidbio-compatible bulking material comprises collagen, fibrin, or elastin.3. The method of claim 2, wherein said bio-compatible bulking materialcomprises collagen in one of the following forms: fibrillar,non-fibrillar, crosslinked, non-crosslinked, aqueous, or denaturedgelatin.
 4. The method of claim 1, wherein said bio-compatible bulkingmaterial comprises a fluoropolymer resin paste, a synthetic polymerichydrogel, a glycoaminoglycan, a proteoglycan, or microbeads suspended ina biological fluid lubricant.
 5. The method of claim 1, wherein saidbio-compatible bulking material is injected through a needle insertedthrough a biopsy channel of an endoscope inserted into the stomach. 6.The method of claim 1, wherein a sewing device is placed through thebiopsy channel and the pylorus is sewn with said device.
 7. The methodof claim 1, further comprising inducing supplemental flaccid paralysesof the stomach wherein a needle is placed through the biopsy channel andbotulinum toxin is injected into the muscles of the fundus.
 8. Themethod of claim 1, further comprising inducing supplemental flaccidparalyses of the stomach wherein a needle is placed through the biopsychannel and botulinum toxin is injected into the antrum of the stomach.